Epstein-Barr (EBV) DNA Quantitative PCR

Test Code: 97713

CPT Code: 87799

Alternative Name(s): EBV DNA QN PCR

Methodology: Polymerase Chain Reaction

Clinical Significance: Epstein-Barr virus (EBV), also known as Human Herpesvirus 4, is a ubiquitous double-stranded DNA virus that belongs to the human herpesvirus family. EBV is one of the most common human-associated viruses in existence; approximately 95% of the world’s adult population has been infected with EBV and remain lifelong carriers.1,2 Primary infection is generally asymptomatic in childhood but can lead to infectious mononucleosis in adolescents and young adults. Following primary infection, the virus establishes lifelong persistence in B cells.

Other EBV-related infections are: chronic active EBV infection as well as lymphoproliferative EBV-infections. Post-transplant lymphoproliferative disease (PTLD), which is EBV-associated in 90% of the cases, is a serious illness which can occur in immunosuppressed transplant recipients.4 There are 2 EBV subtypes, type 1 being dominant in the Western hemisphere and Southeast Asia and type 1 and 2 being equally prevalent in Africa.5 In immunocompromised patients, rising EBV viral titers should raise the suspicion for EBV-related PTLD; however, diagnosis must be confirmed by biopsy.

Quantitative assessment of EBV viral load is one of the most effective methods for supporting clinical management, as it can accurately distinguish healthy low-level carriers from high-level infected patients.8 Even before a disease manifests, high-risk individuals, such as transplant patients, can benefit from regular screening tests to track possible disease progression.8,9 Traditional serological methods for EBV detection are discouraged in immunosuppressed individuals due to the high probability of varied serology profiles and, consequently, real-time PCR is becoming widely accepted as the principal technology for viral load measurement.

Treatment for EBV-related illness varies based on immunocompetence as well as type of EBV-related illness. For EBV-associated PTLD in transplant patients, therapeutic strategies include a reduction in immunosuppression for 2-4 weeks, Rituximab (monoclonal Ab) monotherapy, chemotherapy, EBV-specific cytotoxic T-cell therapy and steroids. The use of antiviral drugs is not recommended due to data showing lack of efficacy.

The Alinity m EBV amplification reagents include primers and probes that amplify and detect dual targets in the EBV genome. Amplification and detection of the two EBV targets ensures sensitive detection of the viral genome even at low levels. In addition to the EBV primers and probes, the assay utilizes an internal control (IC) primer/probe set for amplification and detection of the IC target sequence, which is not related to EBV. The IC probe is labeled with a different fluorophore than the EBV probes. This allows for simultaneous detection and discrimination of both the EBV and IC amplified products within the same reaction vessel.